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The efficacy and safety of a once-daily dose of ANORO ELLIPTA and a twice-daily dose of ADVAIR DISKUS 250 mcg/50 mcg were evaluated in 12-week, multicenter, randomized, double-blind, double-dummy, parallel-group studies in patients (mean age range: 63 to 64 years) with COPD with no exacerbations (COPD symptoms requiring oral corticosteroids, antibiotics, and/or hospitalization) in the previous year. At screening, patients had a mean postbronchodilator FEV1 range of 49.4% to 49.5% predicted. The studies were not powered to compare the safety profiles of the products.

Primary endpoint

Weighted mean FEV1 (0-24 hours postdose) on Day 84.

ANORO provided more patients with a ≥100 mL lung function improvement vs an established ICS/LABA1

The indication for ANORO differs from the indication for ADVAIR in that ANORO is not indicated for reducing COPD exacerbations.

A 24-week, double-blind, placebo-controlled study evaluated the efficacy and safety of ANORO ELLIPTA (n=413), placebo (n=280), and other treatment arms in patients with COPD. The primary endpoint was trough FEV1 at Day 169. For the other endpoint of rescue albuterol use (puffs/day), Weeks 1 to 24, the LS mean
number
of rescue albuterol puffs per day was 3.3 for ANORO and 4.1 for placebo, which corresponds to a 0.8 difference. This endpoint was not adjusted for multiplicity.

A 12-week, double-blind, placebo-controlled study evaluated the efficacy and safety of ANORO ELLIPTA (n=248) compared with placebo (n=248) in patients with COPD. The primary endpoint was the SGRQ total score at Week 12. For the secondary endpoint of rescue albuterol use (puffs/day), Weeks 1 to 12, the LS mean number of rescue albuterol puffs per day was 2.2 for ANORO and 2.9 for placebo, which corresponds to a 0.7 difference (P<0.001).

Important Safety Information

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, one of the active ingredients in ANORO, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths. This finding with salmeterol is considered a class effect of all LABA.

The safety and efficacy of ANORO in patients with asthma have not been established. ANORO is not indicated for the treatment of asthma.

CONTRAINDICATIONS

ANORO is contraindicated in patients with severe hypersensitivity to milk proteins or with hypersensitivity to umeclidinium, vilanterol, or any of the excipients.

WARNINGS AND PRECAUTIONS

ANORO should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD.

ANORO is NOT a rescue medication and should NOT be used for the relief of acute bronchospasm or symptoms. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.

ANORO should not be used more often or at higher doses than recommended or with another LABA (eg, salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, like LABA.

Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of ANORO. Discontinue ANORO if such reactions occur.

Vilanterol can produce clinically significant cardiovascular effects in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, or symptoms. If such effects occur, ANORO may need to be discontinued. ANORO should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.

Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a healthcare provider immediately if signs or symptoms of acute narrow-angle glaucoma develop.

Use with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if signs or symptoms of urinary retention develop.

DRUG INTERACTIONS

Caution should be exercised when considering the coadministration of ANORO with ketoconazole and other known strong CYP3A4 inhibitors as increased systemic exposure to vilanterol and cardiovascular adverse effects may occur. See prior Warning and Precaution regarding CYP3A4 inhibitors.

ANORO should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval, or within 2 weeks of discontinuation of such agents, because they may potentiate the effect of vilanterol on the cardiovascular system.

Use beta‐blockers with caution as they not only block the pulmonary effect of beta‐agonists, such as vilanterol, but may produce severe bronchospasm in patients with COPD.

Use with caution in patients taking non–potassium-sparing diuretics, as ECG changes and/or hypokalemia associated with these diuretics may worsen with concomitant beta-agonists.

Avoid coadministration of ANORO with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report, or call 1-800-822-7967.